Tramadol HCL

Product NDC: 80425-0057
Requested package NDC: 80425-0057-4
11-digit product format: 804250057
Labeler code: 80425
Product ID: 80425-0057_2a98da36-e8b2-759b-e063-6294a90ab33b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tramadol HCL
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA076003
Marketing category: ANDA
Marketing start: 2010-11-15
Substance: TRAMADOL HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076003-001	TRAMADOL HYDROCHLORIDE	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2002-06-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076003-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	TRAMADOL HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2002-06-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076003-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076003-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076003-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076003-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076003-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076003-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076003-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076003-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076003-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076003-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076003-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076003-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076003-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076003-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076003-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076003-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076003-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076003-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076003-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076003-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076003-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076003-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076003-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076003-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076003-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076003-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076003-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076003-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076003-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076003-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076003-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076003-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076003-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076003-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076003-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076003-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076003-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076003-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076003-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076003-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Coupler LLC	54d74939-301b-e603-e063-6394a90a3b03	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Major Pharmaceuticals	6b0b95b2-ae4c-42e8-9f2e-bcdaffda62e2	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	67919c2c-2f8a-4bbb-bef5-0cd6c1e63a16	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals NY LLC	8ec4e4e5-a56e-4198-8428-6b770b9bf27d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	American Health Packaging	f6f6069b-cc75-4b87-afa5-b83001b543e0	2025-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2e738ced-9cde-e776-e063-6294a90a7e33	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Clinical Solutions Wholesale, LLC	728157e2-d153-4ea0-81eb-36599dc7dfda	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5babcfcf-331b-5db9-e053-2a91aa0aaf89	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol HCL	TRAMADOL HCL	Advanced Rx of Tennessee, LLC	af87fc31-07c2-b1f7-e053-2995a90a499f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003 ndc (package): 80425-0057-4 ndc (product): 80425-0057 ndc11 (package): 80425005704
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Amneal Pharmaceuticals LLC	58b802cb-2443-4f5b-9718-7d54c6d50cb4	2021-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003
Tramadol Hydrochloride	TRAMADOL HYDROCHLORIDE	Proficient Rx LP	50f4b752-20af-4ebf-9408-e78f30d2a3cc	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076003 application number: ANDA076003

Additional Listing Data#

Finished product: Yes
Brand name base: Tramadol HCL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRAMADOL HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9N7R477WCK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
835603	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
af87fc31-07c2-b1f7-e053-2995a90a499f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
43d017e1-6ae6-7555-71d1-c249236d6f26	Product name	4	20251117
bff1fbab-f4cc-4993-b7de-2b555ee5eb73	Product name	1	20220509
c563c906-2606-457c-bb1b-5a623daed55b	Product name	1	20210511
43a9f8f9-34aa-8ae8-719e-5489454f7720	Product name	5	20200123
abd2f6f2-3fa7-4571-af8a-d67f89bdcb75	Product name	1	20190927
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
9457302e-0ca3-d9ff-0863-1b24b6107218	Product name	1	20140508
d5c49867-1fe9-7a44-3319-814417011d51	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0057-1	Tramadol HCL	30 in 1 BOTTLE	TABLET, COATED	30	9
80425-0057-2	Tramadol HCL	60 in 1 BOTTLE	TABLET, COATED	60	9
80425-0057-3	Tramadol HCL	90 in 1 BOTTLE	TABLET, COATED	90	9
80425-0057-4	Tramadol HCL	15 in 1 BOTTLE	TABLET, COATED	15	9
80425-0057-5	Tramadol HCL	120 in 1 BOTTLE	TABLET, COATED	120	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0057-1	EA - Each	80425-0057	504be37b-91ad-4507-a4aa-1f8cd3a6f862	1	2023-03-13
80425-0057-2	EA - Each	80425-0057	4c02de54-897e-4e5b-ac17-54b2b024bb79	1	2023-03-13
80425-0057-3	EA - Each	80425-0057	ad860459-e36b-4269-87a3-ee63a4811db7	1	2023-03-13
80425-0057-4	EA - Each	80425-0057	53aa85da-c9bb-42b1-93bb-fd4d2d165c85	1	2023-03-13
80425-0057-5	EA - Each	80425-0057	998304a3-5bc5-44c3-ab3d-2e3b4e522fae	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0057	TRAMADOL HCL TABLET, COATED [ADVANCED RX OF TENNESSEE, LLC]	9	Current NDC, Legacy NDC, 5 package rows	20250101_af87fc31-07c2-b1f7-e053-2995a90a499f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9N7R477WCK	TRAMADOL HYDROCHLORIDE	36282-47-0	TRAMADOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
835603	traMADol HCl 50 MG Oral Tablet	PSN	af87fc31-07c2-b1f7-e053-2995a90a499f	9
835603	tramadol hydrochloride 50 MG Oral Tablet	SCD	af87fc31-07c2-b1f7-e053-2995a90a499f	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0057-4	80425005704	15 TABLET, COATED in 1 BOTTLE (80425-0057-4)	2010-11-15	0000-00-00	No	No	Current